Cleared Abbreviated

K100006 - HS FIBER (POLYBLEND)

K100006 is the FDA 510(k) clearance for HS FIBER (POLYBLEND) by Riverpoint Medical. It is a Class 2 General & Plastic Surgery device (product code GAT) cleared through the Abbreviated 510(k) pathway after a 126-day FDA review.

K100006 · Riverpoint Medical · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2010
Decision
126d
Days
Class 2
Risk

K100006 is an FDA 510(k) clearance for the HS FIBER (POLYBLEND), RIVER BOND, RIVERSILK (SILK), RIVERPRO (POLYPROPYLENE),.... Classified as Suture, Nonabsorbable, Synthetic, Polyethylene (product code GAT), Class II - Special Controls.

Submitted by Riverpoint Medical (Portland, US). The FDA issued a Cleared decision on May 10, 2010 after a review of 126 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5000 - the FDA general and plastic surgery device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Riverpoint Medical devices

Submission Details

510(k) Number K100006 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 2010
Decision Date May 10, 2010
Days to Decision 126 days
Submission Type Abbreviated
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 115d · This submission: 126d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code GAT Suture, Nonabsorbable, Synthetic, Polyethylene
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5000
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GAT Suture, Nonabsorbable, Synthetic, Polyethylene

All 95
Devices cleared under the same product code (GAT) and FDA review panel - the closest regulatory comparables to K100006.
ARTHREX SUTURE (UHMWPE)
K122374 · Arthrex, Inc. · Sep 2012
ARTHREX BIO-SUTURE
K112899 · Arthrex, Inc. · Apr 2012
V-LOC(TM) NONABSORBABLE WOUND CLOSURE DEVICE
K103052 · Covidien, LLC · Nov 2010
FORCE FIBER GREEN ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE NON ABSORBABLE SUTURES MODEL:X-5000FFK, X-5001FFK, X-5002FFK
K100506 · Teleflex Medical · Mar 2010
FAST-FIX 360 MENISCAL REPAIR SYSTEM, STRIAGHT, CURVED, REVERSE CURVED,FAST FIX 360 AB MENISCAL REPAIR SYSTEM, STRAIGHT,
K092508 · Smith & Nephew, Inc. · Jan 2010
MENISCAL CINCH
K073149 · Arthrex, Inc. · Feb 2008